Tutoplast Processed Pericardium is restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional (i.e., physician). This includes grafting for horizontal and vertical soft tissue augmentation of thickness and length. The implant is provided sterile and requires rehydration prior to use.

Donor Screening & Tissue Processing

The donated human tissue utilized for this implant was recovered from a donor screened for risk factors associated with infectious diseases and medical conditions that rule out donation. The donor’s blood was tested for relevant communicable diseases in a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 or equivalent, and registered with the US Food and Drug Administration for donor testing.

Warnings/Precautions:

The same potential medical/ surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any human tissue implant, it is not possible to guarantee freedom from transmission of infectious agents or other adverse reactions such as hypersensitivity, allergic or immune response.

Prior to use, the surgeon must become familiar with the implant and the surgical procedure. Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for procedures using this implant; as such conditions may compromise outcomes.

The implant should be used with caution in surgical sites where an active infection is present or in sites with poor perfusion. If the surgeon determines that the clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

Appropriate placement and fixation of the implant are critical to success of the surgical procedure.